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Loma Linda University Medical Center Loma Linda, CA 92354

 
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I would like to thank Dr. Ng and colleagues for their interest in and response to our article [1] about gadodiamide-associated nephrogenic systemic fibrosis. In their letter to the editor, they object to our recommendation to avoid using single-dose gadolinium-based contrast media in patients with end-stage renal disease with a creatinine clearance rate or GFR of < 15 mL/min. Although none of the patients in our study developed nephrogenic systemic fibrosis after receiving a single dose (0.1 mmol/kg) of gadodiamide, we made these recommendations based on the initial U.S. Food and Drug Administration (FDA) Public Health Advisory [2] that was released in June 2006 because we think that those recommendations are reasonable and prudent.

Although we did not report this case in our article [1], we had one other patient who we strongly believe developed nephrogenic systemic fibrosis after receiving a 0.1 mmol/kg dose of gadodiamide on the basis of the clinical findings, onset of symptoms, and sequential calf MRI findings, which were similar to those presented in our article. Unfortunately, we did not have a confirmatory skin biopsy for that case.

Since our article was published, two other groups of investigators have reported in different publications cases of nephrogenic systemic fibrosis after using a dose of gadodiamide of < 0.2 mmol/kg [3, 4]. In December 2006, the FDA updated their public health advisory to caution against the use of gadolinium-based contrast media in patients with renal insufficiency, extending the window of risk to include patients with moderate and severe renal insufficiency (GFR < 60 mL/min), in addition to those with end-stage renal disease [5]. They also added that cases of nephrogenic systemic fibrosis had been reported with single- and double-dose administration of gadolinium-based contrast media.

We also disagree with the contention that nephrogenic systemic fibrosis is not more prevalent with increasing severity of renal insufficiency. Based on the early reporting of nephrogenic systemic fibrosis in the medical literature and to the FDA, most cases of nephrogenic systemic fibrosis have occurred in patients with end-stage renal disease, followed in frequency by patients with severe and moderate renal insufficiency.

In their letter, Dr. Ng and colleagues present their unpublished data regarding the use of single-dose gadolinium-based contrast media in 25 patients with end-stage renal disease, none of whom developed nephrogenic systemic fibrosis. It is not clear which gadolinium-based contrast agent was used, nor do they specify what sort of clinical follow-up was obtained on those patients. It is important to emphasize which gadolinium chelate was used because certain chelates, such as gadodiamide, appear to be more frequently associated with nephrogenic systemic fibrosis. Moreover, delayed clinical follow-up at 3–4 months is essential to exclude the development of this condition.

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1. Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA. Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR 2007;188 : 586–592[Abstract/Free Full Text]
2. U.S. Food and Drug Administration Website. Public health advisory: gadolinium-containing contrast agents for magnetic resonance imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. June 8, 2006. Available at: http://www.fda.gov/cder/drug/advisory/gadolinium_agents.htm. Accessed November 30, 2006
3. Sadowski EA, Bennett LK, Chan MR, et al. Nephrogenic systemic fibrosis: risk factors and incidence estimation. Radiology 2007; 10.1148Jan 31;Epub ahead of print
4. Khurana A, Runge VM, Narayanan M, Greene JF, Nickel AE. Nephrogenic systemic fibrosis: a review of 6 cases temporally related to gadodiamide injection (Omniscan). Invest Radiol 2007;42 : 139–145[CrossRef][Medline]
5. U.S. Food and Drug Administration Website. Public health advisory: gadolinium-containing contrast agents for magnetic resonance imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. December 22, 2006. Available at: www.fda.gov/cder/drug/advisory/gadolinium_agents.htm. Accessed February 7, 2007

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This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Broome, D. R. Articles by Girguis, M. S. Search for Related Content PubMed Articles by Broome, D. R. Articles by Girguis, M. S. Social Bookmarking                      What's this?